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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

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[EPA–HQ–OPP–20[08]–[0529]; FRL–XXXX–X]

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RIN 2070–[Tolerances are exempt, unless proposed by EPA. If proposed, use the 

proposed rule’s RIN.]

[Laminarin]; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an exemption from the requirement of a 

tolerance for residues of [laminarin in or] on [all food commodities] when applied

preharvest [as a biochemical pesticide to stimulate natural defense mechanisms in 

plants]. [Laboratoires Goëmar SA c/o SciReg, Inc.] submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the 

requirement of a tolerance. This regulation eliminates the need to establish a maximum 

permissible level for residues of [laminarin].

DATES: This regulation is effective [insert date of publication in the Federal Register]. 

Objections and requests for hearings must be received on or before [insert date 60 days 

after date of publication in the Federal Register], and must be filed in accordance with 

the instructions provided in 40 CFR part 178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket identification 

(ID) number EPA–HQ–OPP–20[08]–[0529]. All documents in the docket are listed in the 

docket index available at http://www.regulations.gov. Although listed in the index, some 

information is not publicly available, e.g., Confidential Business Information (CBI) or 

other information whose disclosure is restricted by statute. Certain other material, such as 

copyrighted material, is not placed on the Internet and will be publicly available only in 

hard copy form. Publicly available docket materials are available in the electronic docket 

at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory 

Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
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Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–

5805.

FOR FURTHER INFORMATION CONTACT: [Chris Pfeifer], Biopesticides and 

Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: [703-308-

0031]; e-mail address: [pfeifer.chris]@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, 

food manufacturer, or pesticide manufacturer. Potentially affected entities may include, 

but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for 

readers regarding entities likely to be affected by this action. Other types of entities not 

listed in this unit could also be affected. The North American Industrial Classification 

System (NAICS) codes have been provided to assist you and others in determining 

whether this action might apply to certain entities. If you have any questions regarding 

the applicability of this action to a particular entity, consult the person listed under FOR 

FURTHER INFORMATION CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

You may access a frequently updated electronic version of 40 CFR part 180 

through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an 

objection to any aspect of this regulation and may also request a hearing on those 

objections. The EPA procedural regulations, which govern the submission of objections 

and requests for hearings, appear in 40 CFR part 178. You must file your objection or 

request a hearing on this regulation in accordance with the instructions provided in 40 

CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number 
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EPA–HQ–OPP–20[08]–[0529] in the subject line on the first page of your submission. 

All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on 

or before [insert date 60 days after date of publication in the Federal Register].

In addition to filing an objection or hearing request with the Hearing Clerk as 

described in 40 CFR part 178, please submit a copy of the filing that does not contain any 

CBI for inclusion in the public docket that is described in ADDRESSES. Information not 

marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 

without prior notice. Submit your copies, identified by docket ID number EPA–HQ–

OPP–20[08]–[0529], by one of the following methods.

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 

instructions for submitting comments.

• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

20460–0001.

• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection 

Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 

VA. Deliveries are only accepted during the Docket Facility's normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special 

arrangements should be made for deliveries of boxed information. The Docket Facility

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of [July 31, 2008] ([73] FR [44719]) (FRL–8374–3), 

EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide tolerance petition (PP [7E7276]) by [Laboratoires 

Goëmar SA c/o SciReg, Inc.], [12733 Director’s Loop, Woodbridge, VA 22192]. The 

petition requested that 40 CFR part 180 be amended by establishing an exemption from 

the requirement of a tolerance for residues of [laminarin]. A summary of the petition 

prepared by the petitioner [Laboratoires Goëmar SA c/o SciReg, Inc.] was included in 

the docket for this action. [There were no comments received in response to the 

notice of filing].

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from 

the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a 

food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of 

FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will 

result from aggregate exposure to the pesticide chemical residue, including all anticipated 

dietary exposures and all other exposures for which there is reliable information.” This 

includes exposure through drinking water and in residential settings, but does not include 

occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or 

maintaining in effect an exemption from the requirement of a tolerance, EPA must take 

into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA 
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to give special consideration to exposure of infants and children to the pesticide chemical 

residue in establishing a tolerance and to “ensure that there is a reasonable certainty that 

no harm will result to infants and children from aggregate exposure to the pesticide 

chemical residue....” Additionally, section 408(b)(2)(D) of FFDCA requires that the 

Agency consider “available information concerning the cumulative effects of a particular 

pesticide's residues” and “other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate 

exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, 

EPA examines exposure to the pesticide through food, drinking water, and through other 

exposures that occur as a result of pesticide use in residential settings.

III. Toxicological Profile

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available 

scientific data and other relevant information in support of this action and considered its 

validity, completeness, and reliability and the relationship of this information to human 

risk. EPA has also considered available information concerning the variability of the 

sensitivities of major identifiable subgroups of consumers, including infants and children.

[Laminarin, a naturally occurring β-glucan (polysaccharide carbohydrate), 

may be extracted from many types of brown algae (e.g., Laminaria digitata).

Generally, β-glucans are major constituents in the bran of most cereal grains and 

are intentionally added to many dietary supplements and texturing agents; 

therefore, these carbohydrates are typically consumed as a regular part of the 

human diet. Laminarin, specifically, is an integral part of the human diet in 

countries such as Ireland, France, and Japan, where Laminaria digitata is used for

sea-vegetable production. As a biochemical active ingredient, laminarin stimulates 

the natural defense reactions of agricultural crops such as fruiting vegetables, 

tomato, eggplant, pepper, zucchini, cucurbits, watermelon, melons, grape, apple, 

pear, and strawberries against particular disease organisms (e.g., gray mold, 

powdery mildew, downy mildew, fire blight, and bacterial spot). As a naturally 

occurring oligosaccharide (a carbohydrate), residues of the active ingredient are 

indistinguishable from other naturally occurring plant oligosaccharides. In addition 

to the extensive history of consumption of β-glucans—particularly laminarin in this 

case—without documented toxicological effects, the data submitted to the Agency, in 

conjunction with and in support of this tolerance exemption, confirm that laminarin 

is virtually nontoxic and poses no dietary risks to humans. 

Because laminarin is considered “toxicologically innocuous,” no residue studies 

are required to support a tolerance exemption. However, laminarin’s low toxicity 

profile notwithstanding, another justification for this exemption from the 

requirement of a tolerance is the unlikelihood of residues for this biochemical 

pesticide in or on food. Laminarin is intended for application as a systemic acquired 

resistance (SAR) inducer—a preventative mode of action. As such, it is applied early 

in a crop’s life cycle—in its growing stages—to help build immunity to disease 

organisms such as mold and bacterial infection. Furthermore, as a biochemical, it is 
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prone to biodegrade rapidly. Data indicate that the active ingredient is more than 

65% biodegraded after two weeks (Master Record Identification Number (MRID 

No.) 472649-54). Calculations indicate that it would be fully biodegraded long before 

any consumption would occur because the most likely final application of the 

pesticide would occur early in the growing season for plants treated with this 

pesticide. Accordingly, no exposures beyond background levels are expected. 

Summaries of the toxicological data submitted in support of this exemption 

from the requirement of a tolerance follow: 

A. Acute Toxicity: Acute toxicity studies, submitted to support the registration of 

the end-use product containing laminarin, confirm a low toxicity profile and 

buttress the finding that this active ingredient poses no significant human health 

risk with regard to new food uses. Altogether, the acute toxicity data show 

virtual nontoxicity for all routes of exposure and suggest that any dietary risks 

associated with this carbohydrate would be negligible.

1. The acute oral median lethal doses (LD50s) in rats were greater than 2,000

milligrams per kilogram (mg/kg) and confirmed negligible toxicity through the 

oral route. There were no observed toxicological effects on the test subjects in

either of the two acute oral studies submitted (Master Record Identification 

Numbers (MRID Nos.) 472649-30 and 472649-73). Laminarin is Toxicity 

Category III for acute oral toxicity.

2. The acute dermal median lethal dose (LD50) in rats was greater than 5,000 

mg/kg. These data substantiated laminarin’s relative dermal nontoxicity to the 

general public (MRID Nos. 472649-31 and 472649-74). Laminarin is Toxicity 

Category IV for acute dermal toxicity. 

3. The acute inhalation median lethal concentration (LC50) was greater than 1.02

milligrams per liter (mg/L) in rats and showed no significant inhalation toxicity 

(MRID No. 472649-32). Laminarin is Toxicity Category III for acute inhalation 

toxicity.

4. A skin irritation study on rabbits indicated that laminarin was not irritating to 

the skin (MRID No. 472649-34). Laminarin is Toxicity Category IV for dermal 

irritiation.

5. Data indicated laminarin is not a dermal sensitizer (MRID Nos. 472649-35 and 

472649-78). 

Data indicate that laminarin is not acutely toxic. No toxic endpoints were 

established in any of the acute toxicity studies; and no significant toxicological 

effects were observed in any of the acute toxicity studies.

B. Mutagenicity: Three mutagenicity studies, using laminarin as the test substance, 

were performed. These studies are sufficient to confirm that there are no 

expected dietary or non-occupational risks of mutagenicity with regard to new 

food uses.
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1. The Reverse Mutation Assay (MRID No. 472649-42) showed that laminarin did 

not induce mutant colonies relative to control groups. 

2. The In vitro Mammalian Cells in Culture Assay (MRID No. 472649-43) 

demonstrated that laminarin did not damage chromosomes or the mitotic 

apparatus of bone marrow cells. 

3. A Bone Marrow Micronucleus Assay (MRID No. 472649-44) indicated that no 

toxicity was noted in either sex at any dose up to the limit dose of 2,000 mg/kg.

C. Subchronic Toxicity: Based on its biodegradation properties, residues of 

laminarin are not expected to result in significant dietary exposure beyond the 

levels expected in background dietary exposures. Nonetheless, three subchronic 

oral toxicity studies satisfied the data requirements for subchronic toxicity and 

indicated that laminarin has no subchronic toxicological effect. 

1. A 28-day Oral Toxicity Study (MRID No. 472649-37) found no toxicological 

effects regarding mortality, clinical observations, neurotoxicity assessment, body 

weight, food consumption, hematology, clinical chemistry, organ weights, and 

macroscopic or microscopic observations. The no observable effect level (NOEL)

was determined to be 1,000 milligrams per kilogram per day (mg/kg/day). 

2. A 90-day Oral Toxicity Study (MRID No. 472649-38) found no statistical 

difference in hematology, clinical chemistry, or urinalysis between test subjects 

and the control. The NOAEL was determined to be 1,000 mg/kg/day. 

3. Another 90-day Oral Toxicity Study (MRID No. 472649-39) also found no 

statistical difference in hematology, clinical chemistry, or urinalysis between test 

subjects and the control. The NOAEL was again determined to be 1,000 

mg/kg/day.

D. Developmental Toxicity: The data submitted to the Agency demonstrate a clear 

lack of developmental toxicity and supports the Agency’s conclusion that there is 

no risk of developmental toxicity associated with new food uses. Data submitted 

to the Agency satisfy the data requirements for developmental toxicity and 

indicate that laminarin poses negligible risk with regard to developmental 

toxicity.

1. A Prenatal Developmental Toxicity Study (MRID No. 472649-40) found no 

significant treatment-related reproductive effects or fetal abnormalities and 

established a no observable adverse effect level (NOAEL) of 1,000 mg/kg/day. 

2. A second Prenatal Developmental Toxicity Study (MRID No. 472649-41) also 

found no significant treatment-related reproductive effects or fetal abnormalities 

and confirmed a NOAEL of 1,000 mg/kg/day.

E. Effects on Endocrine Systems: There is no available evidence demonstrating 

that laminarin is an endocrine disruptor in humans. As a result, the Agency is 

not requiring information on the endocrine effects of laminarin at this time.

However, the Endocrine Disruption Screening Program (EDSP) has established 

a protocol, which guides the Agency in selecting suspect ingredients for review, 
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and the Agency reserves the right to require new information should the 

program require it. Presently, based on the lack of exposure and the negligible 

toxicity profile of laminarin, no adverse effects to the endocrine are known or 

expected. Overall, the lack of evidence of endocrine disruption is consistent with 

laminarin’s low toxicity profile and supports this exemption from the 

requirement of a tolerance.]

IV. Aggregate Exposures

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider 

available information concerning exposures from the pesticide residue in food and all 

other non-occupational exposures, including drinking water from ground water or surface 

water and exposure through pesticide use in gardens, lawns, or buildings (residential and 

other indoor uses).

A. Dietary Exposure

[Because of laminarin’s ability to biodegrade relatively quickly and the 

typical time during plant growth that it will be applied, the Agency does not 

anticipate many residues being present in or on food at the time of consumption. 

Moreover, any residues that are present in or on food at the time of consumption as 

a result of pesticide use are likely to be indistinguishable from naturally occurring 

laminarin due to its natural occurrence and ubiquitous presence in foods and 

dietary supplements. Finally, the Agency believes that it is unlikely that any 

exposure to the residues of laminarin will result in dietary risks because of the 

nontoxic mode of action as a SAR inducer and the pesticide’s negligible toxicity 

profile.]

1. Food. [Exposure to residues of laminarin on foods is expected to be 

negligible. Data submitted to the Agency show that laminarin is 65% to 71% 

biodegraded within two weeks, and that it hydrolyzes very rapidly into glucose.

Because applications necessarily occur early in the growing season (due to its mode 

of action as a SAR inducer), and given its short-lived presence on crops, no 

significant pesticidal residues are anticipated for harvested foods. However, in the 

event of exposure to residues of laminarin, no dietary risks are anticipated. As 

described in Unit III, acute, subchronic, mutagenic and developmental studies 

support its nontoxic profile. Furthermore, it is already present in foods without any 

known detrimental effects. Indeed, there is no information in the public literature 

suggesting any health issues to either animals or plants relative to this compound. 

Lastly, proposed rates of application of laminarin will result in substantially fewer 

residues in or on foods as a result of pesticide application than the quantities of 

laminarin already consumed in foods and those allowed in dietary supplements. In 

sum, no dietary exposure is expected; however, any potential dietary exposures 

would not be expected to pose any quantifiable risk, mainly due to laminarin’s

nontoxic profile.]

2. Drinking water exposure. [Residues of laminarin are not expected to be 
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present in drinking water as applications of laminarin are made directly to 

terrestrial crops. Laminarin residues are not expected to percolate through the soil 

because residues are not expected to persist beyond the time it would typically take

for any residues to percolate into the groundwater. In the event of errant spray drift 

or extraordinary rainfall, laminarin will not persist in water due to its rapid 

hydrolyzation into glucose. Moreover, given laminarin’s nontoxic profile as 

described in Unit III, risks from miniscule aquatic exposure would be negligible. 

Altogether, drinking water exposure is not expected to pose any quantifiable risk 

due to both a lack of residues and the nontoxicity of laminarin.] 

B. Other Non-Occupational Exposure

[Non-occupational exposure is not expected because lamarin is not approved 

for residential uses. The active ingredient is applied directly to commodities and 

degrades rapidly. Furthermore, the Agency notes that health risks are not expected 

from any pesticidal exposure to this active ingredient, no matter the circumstances.

An August 2009 Agency risk assessment of laminarin clearly establishes that even 

prolonged and regular occupational exposures, which are associated with this active 

ingredient, pose negligible risks. Laminarin is characterized by its biodegradability, 

low toxicity profile, nontoxic, SAR-inducing mode of action, and demonstrable lack 

of dietary effects.]

1. Dermal exposure. [Non-occupational dermal exposures to laminarin are 

expected to be negligible because of its directed agricultural use. Even in the event 

of dermal exposure to residues, the nontoxic profile of laminarin (as described in 

Unit III) is not expected to result in any risks through this route of exposure.]

2. Inhalation exposure. [Non-occupational inhalation exposures are not 

expected to result from the agricultural uses of laminarin. Any inhalation exposure 

associated with this new agricultural use pattern is expected to be occupational in 

nature.]

V. Cumulative Effects

[Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available 

information concerning the cumulative effects of exposure to laminarin residues and 

other substances that have a common mechanism of toxicity. These considerations 

include the possible cumulative effects of such residues on infants and children. 

Because laminarin operates through a nontoxic mode of action, there is no common 

mechanism of toxicity between this and any other substances; therefore, this 

provision does not apply. Nevertheless, given that no exposure to residues are 

expected when applications are made in accordance with EPA-approved labeling 

and good agricultural practices, and laminarin has a long history of dietary 

consumption without incident, the Agency concludes that there is no reason to 

anticipate cumulative effects from the residues of this active ingredient with other 

related pesticides.]
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VI. Determination of Safety for U.S. Population, Infants and Children

[Health risks to humans, including infants and children, are considered 

negligible with regard to the pesticidal use of laminarin. As illustrated in Unit III, 

acute toxicity studies indicate that laminarin has negligible toxicity. It is ubiquitous 

in nature and present in fruits and vegetables. To date, there is no history of 

toxicological incident involving its consumption and its use in food supplements is 

already allowed by the United States Food and Drug Administration. Of equal note,

little to no exposure to the residues of laminarin is expected. Pesticidal applications 

are applied directly to agricultural crops, and data suggest that residues are not 

expected beyond the time of harvest. Accordingly, little to no dietary exposure is 

expected. As such, the Agency has determined that this food use of laminarin poses 

no foreseeable risks to human health or the environment. Thus, there is a 

reasonable certainty of no harm to the general U.S. population, including infants 

and children, from exposure to this active ingredient.

1. U.S. population. The Agency has determined that there is a reasonable 

certainty that no harm will result from aggregate exposure to residues of laminarin 

to the U.S. population. This includes all anticipated dietary exposures and other 

non-occupational exposures for which there is reliable information. The Agency 

arrived at this conclusion based on the low levels of mammalian dietary toxicity 

associated with laminarin, the natural ubiquity of laminarin in foodstuffs, and 

information suggesting that the pesticidal use of laminarin will not result in a 

significant, if any, exposure. For these reasons, the Agency has determined that 

laminarin residues in and on all food commodities will be safe, and that there is a 

reasonable certainty that no harm will result from aggregate exposure to residues of 

laminarin. 

2. Infants and children. FFDCA section 408(b)(2)(C) provides that EPA shall 

assess the available information about consumption patterns among infants and 

children, special susceptibility of infants and children to pesticide chemical residues, 

and the cumulative effects on infants and children of the residues and other 

substances with a common mechanism of toxicity. In addition, FFDCA section 

408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of exposure 

(safety) for infants and children in the case of threshold effects to account for 

prenatal and postnatal toxicity and the completeness of the database unless the EPA 

determines that a different margin of exposure (safety) will be safe for infants and 

children. Margins of exposure (safety), which are often referred to as uncertainty 

factors, are incorporated into EPA risk assessments either directly or through the 

use of a margin of exposure analysis, or by using uncertainty (safety) factors in 

calculating a dose level that poses no appreciable risk.

Based on all the information evaluated for laminarin, the Agency concludes 

that there are no threshold effects of concern and, as a result, the provision 

requiring an additional margin of safety does not apply.] 

VII. Other Considerations
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A. Endocrine Disruptors

[There is no evidence, at this time, that suggests that laminarin will 

compromise the endocrine system, function in a manner similar to any known 

hormone, or act as an endocrine disruptor.]

B. Analytical Method(s)

[Through this action, the Agency proposes an exemption from the 

requirement of a tolerance of laminarin when used on food commodities, without 

any numerical limitations for residues. EPA has determined that residues resulting 

from the pesticidal use of laminarin are unlikely, and that there are no significant 

toxicity concerns in the event that residues of the active ingredient are present. As a 

result, the Agency has concluded that an analytical method is not required for 

enforcement purposes for laminarin.]

C. Codex Maximum Residue Level

[There are no codex maximum residue levels established for residues of 

laminarin.]

VIII. Conclusions

[Based on the data submitted to support this tolerance exemption, and other 

information available to the Agency, EPA is establishing an exemption from the 

tolerance requirements, pursuant to FFDCA section 408(c), for residues of 

laminarin in or on all food commodities.]

IX. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of FFDCA in response 

to a petition submitted to the Agency. The Office of Management and Budget (OMB) has 

exempted these types of actions from review under Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule 

has been exempted from review under Executive Order 12866, this final rule is not 

subject to Executive Order 13211, entitled Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or 

Executive Order 13045, entitled Protection of Children from Environmental Health Risks 

and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any

information collections subject to OMB approval under the Paperwork Reduction Act 

(PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under 

Executive Order 12898, entitled Federal Actions to Address Environmental Justice in 

Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 

Since tolerances and exemptions that are established on the basis of a petition 

under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the 

issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply.
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Directions

This final rule directly regulates growers, food processors, food handlers, and 

food retailers, not States or tribes, nor does this action alter the relationships or 

distribution of power and responsibilities established by Congress in the preemption 

provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this 

action will not have a substantial direct effect on States or tribal governments, on the 

relationship between the national government and the States or tribal governments, or on 

the distribution of power and responsibilities among the various levels of government or 

between the Federal Government and Indian tribes. Thus, the Agency has determined that 

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and 

Executive Order 13175, entitled Consultation and Coordination with Indian Tribal 

Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In 

addition, this final rule does not impose any enforceable duty or contain any unfunded 

mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4).

This action does not involve any technical standards that would require Agency 

consideration of voluntary consensus standards pursuant to section 12(d) of the National 

Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, 

section 12(d) (15 U.S.C. 272 note).

X. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that 

before a rule may take effect, the agency promulgating the rule must submit a rule report 

to each House of the Congress and to the Comptroller General of the United States. EPA 

will submit a report containing this rule and other required information to the U.S. 

Senate, the U.S. House of Representatives, and the Comptroller General of the United 

States prior to publication of this final rule in the Federal Register. This final rule is not 

a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural 

commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: ________

________________

Click -- Select Title

Therefore, 40 CFR chapter I is amended as follows:
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PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

2. Section 180.[insert CFR cite] is added to subpart D to read as follows:

§ 180.[insert CFR cite] [Laminarin; Exemption from the Requirement of a 

Tolerance].

[An exemption from the requirement of a tolerance is established for

residues of laminarin in or on all food commodities when laminarin is applied

preharvest.]

[FR Doc. ??–???? Filed ??–??–??; 8:45 am]

BILLING CODE 6560–50–S